Dr. Lumpkin leads the Bill and Melinda Gates Foundation’s strategic initiatives around global regulatory systems, including working with partners such as the World Health Organization and other multinational organizations, regional regulatory harmonization/alignment initiatives, and national and regional medical products regulatory authorities. These initiatives are focused on making regulatory systems and processes more efficient and effective to help get medical products sooner to patients who need them in low- and middle-income countries, without sacrificing product quality and safety. Formerly he was deputy commissioner for International and Special Programs at the FDA.